环孢素治疗糜烂型口腔扁平苔藓的随机对照试验

Cyclosporine for treatment of erosive oral lichen planus: A randomized controlled trial

目的研究环孢素治疗糜烂型口腔扁平苔藓的疗效和安全性。方法采用随机对照试验设计,将60例糜烂型口腔扁平苔藓患者随机分为2组(随机数字表法),每组各30例,分别给予与环孢素(试验组)和氟轻松软膏(对照组)治疗6周,治疗结束后评价疗效和不良反应,并于3个月后复查。结果治疗结束后评价疗效:试验组有效率93.3%,对照组96.7%,试验组视觉量表值(VAS)为24.73±15.65,对照组为34.27±16.36。统计后2种药物在促进病损愈合方面疗效差异无统计学意义(χ2=0.351,P>0.05),环孢素在减轻患者疼痛方面优于氟轻松(P<0.05)。治疗过程中不良反应发生率环孢素比氟轻松低。3个月后复查:试验组有效率96.7%,对照组80.0%。试验组VAS值为26.63±17.01,对照组为37.37±18.43。统计结果显示环孢素在缩小病损面积(χ2=4.043,P<0.05)、减轻疼痛方面(P<0.05)均优于氟轻松。结论环孢素治疗糜烂型口腔扁平苔藓比氟轻松有着更肯定的疗效和安全性,值得临床进一步推广应用。

Objective To compare the efficacy and the safety of cyclosporine with fluocinolone acetonide for treatment of erosive oral lichen planus. Methods Randomized controlled trial design：a total of 60 erosive OLP patients were randomly divided into two groups （using random table）,with 30 patients in each group, and were given cyclosporine（ test group） and fluocinolone acetonide ointment （ control group） respectively for 6 weeks. The efficacy and safety were evaluated at the end of treatment. Make a review 3 months later. Results Effective rate of test group was 93.3% ,control group 96.7%. Visual Analogue Score of test group was 24.73 ± 15.65 ,con- trol group 34.27 ± 16.36. After treatment there was not significantly difference between two medicines to promote lesion healing（ X2 = 0. 351 ,P 〉 0.05 ）. Cyclosporine was better than fluocinolone acetonide in relieving pain（ P 〈 0.05 ）. The incidence of adverse reaction of cyclosporine was less than fluocinolone acetonide during treatment process. The review after 3 month ：effective rate of test group was 96.7% ,control group 80.0%. VAS of test group was 26.63 ± 17.01 ,control group 37.37 ± 18.43. Cyclosporine was better than fluocinolone acetonide in promoting lesion healing（x2 =4.043,P 〈0.05） and relieving pain（P 〈0.05）. Conclusions Cyclosporine has more positive efficacy and safety than fluocinolone acetonide. Cyclosporine is worthy of further clinical application.